Health Claims Is it Working?

Transcription

1 Health Claims Is it Working? Nigel Baldwin Director of Scientific& Regulatory Consulting, Europe

2 Key Points The point of the legislation in the first place Progress to date Winners and Losers Understanding EFSA Committees and Working Groups Fallout onto other legislation l Is it working so far? The future Will innovation suffer? Are we benefitting the consumer?

3 Progress to Date Number of claims given a favourable opinion by EFSA

4 Progress to Date Number of claims formally approved by the Commission

5 Winners Most vitamins and minerals have a range of claims they can make E.g. Calcium and claims related to bone and teeth; muscle function and neurotransmission; blood coagulation; energyyielding metabolism; function of digestive enzymes; cell division and differentiation. DHA and omega-3 s Brain, eye, heart claims for general population and children New Innovative ingredients Water-soluble tomato concentrate All sorts of claims for chewing gum Xylitol, polyols, sugar free gum, etc.

6 Probiotics Losers EFSA consensus and expertise in this areas seriously questioned Weight loss (and related) ingredients Most have failed Botanicals (so far!) Proprietary formulated products and combinations Antioxidants (in general) Immunity claims (in general)

7 Understanding EFSA Committees and Working Groups The power-brokers the plenary does not have the whole story but has the last say The Plenary can over-rule the decision of the Working Group It is clear that there are key potential opinion formers in the process The more experts that volunteer for EFSA, the greater the possibility for scientific discussion and debate prior to the implementation of key decisions The opinion formers may well be reluctant volunteers in many cases and would welcome argument

8 Committees and Working Groups NDA Plenary Standing Working Group Claims Sub Group 1 Gut/Immune GI Sub Group 2 Cardio/Antioxidants C/A Acronym NDAP SWGC Sub Group 3 Bone, Dental, Connective Tissue BDC Weight, Satiety, Physical, Sub Group 4 Performance WSPP Sub Group 5 Mental Nervous System MNS Sub Group 6 Characterisation of Botanicals CB Food Allergy Infant Fomulae Novel Foods Population Reference Intakes FA IT NF PRI

9 EFSA Health Claims Experts on <1 NDA Committees Name Country Number of Committees Committee VAN LOVEREN Netherlands 6 NDA, SWGC, GI (C),C/A, FA, NF SALMINEN Finland 5 NDA, SWGC, GI, IF, NF PRZYREMBEL Germany 5 NDA, SWGC, BDC, IF (C), PRI BRESSON France 5 NDA, SWGC, GI, IF, PRI VERHAGEN Netherlands 4 NDA, SWGC, CB (C), NF TETENS Denmark 4 NDA, SWGC, WSPP (C), PRI STROBEL Germany 4 NDA, GI, FA(C), IF STRAIN Ireland 4 NDA, SWGC(C), MNS (C), PRI MARTIN France 4 NDA, SWGC, C/A(C), PRI (C) LOVIK Norway 4 NDA, SWGC, GI, FA FLYNN Ireland 4 NDA (C), SWGC, BDC(C), PRI FAIRWEATHER-TAIT UK 4 NDA, SWGC, MNS, PRI AGOSTONI Italy 4 NDA, SWGC, IF, PRI TOME France 3 NDA, GI, PRI SANZ Spain 3 NDA, SWGC, GI SAARELA 3 GI, IF, NF NEUHAUSER-BERTHOLD Germany 3 NDA, NF, PRI MOSELEY UK 3 NDA, GI, NF MARCHELLI Italy 3 NDA, FA, NF LAGIOU Greece 3 NDA, FA, NF HEINONEN 3 SWGC, C/A, NF GOLLY Ireland 3 NDA, SWGC, NF KORHONEN Finland 2 NDA, SWGC

10 EFSA Opinions Whilst EFSA does allow the applicant to review the draft, it never changes its mind on the outcome of a given opinion Whilst there is a public comment period and lots of people submit detailed scientific arguments EFSA never changes its mind on the outcome of a given opinion A new application is nearly always required taking into account EFSA s rebuttals to such comments

11 EFSA Opinions Beauty is in the eye of the beholder The larger the group the more chance a fair consensus is achieved Perhaps rotating experts could help keep the approach more impartial The decision on whether to deliver a positive or a negative opinion is made fairly early in the review process and the rest is just aligning the detail

12 Deficiencies of Health Claim Applications Noted in Negative EFSA Opinions Scientific Deficiency Insufficient characterisation of the food/food constituent Claimed effect was not considered d a beneficial physiological effect Article 13.1 Claims Article 13.5 Claims Disease-Risk Reduction Article 14 Claims Children s Health and Development 16% 16% 12% 28% 37% 20% 29% 25% Cause and effect 78% 100% 100% 100% relationship was not established

13 The fallout onto other legislation In theory you can do novel foods and health claims in parallel We need to ensure that this remains the case to save time to market EFSA treats each separately E.g. Betaine has positive health claims opinion but has been specifically rejected as a novel food (because of a negative opinion of safety from the same panel of EFSA) This is OK in that you cannot sell it until novel food issues are resolved and it is approved

14 Is it working so far? Its getting better as it progresses (and more positive opinions are coming out) There will at least be some claims to chose from Innovators (e.g. Provexis) are rewarded The science is being rigorously assessed There some irritating inconsistencies in approach There are some very ingrained opinions on both sides The real experts in many cases are prevented from being The real experts in many cases are prevented from being involved because of perceived impartiality which is a huge problem for the probiotics industry

15 The Future Member States have more responsibilities for pre-checks (they are taking more time reviewing dossiers before accepting) EFSA reorganisation will involve central applications desk for communication with applicants (one size does not fit all however) There are fundamental problems with probiotics that can only be resolved by changing the EFSA committee membership More experts should volunteer

16 The Future Botanicals are set to be a complete nightmare So far the industry has only bought time and words from the Commission EFSA is unlikely to change its approach Medical Device registrations are being looked at in some Medical Device registrations are being looked at in some cases but product applications claims are really limited and eventually this avenue will probably be closed

17 The future? Will there be a recast of the Regulation? Probably not Expert certification and self assessment with scrutiny would be a progressive approach... Will there be amendments to clarify and tidy? Probably Will the fundamental principles p of scientific assessment change? Almost certainly not

18 Will Innovation Suffer? Bad innovation (the cowboys ) will be out of the game For a number of existing ingredient groups it will reinforce messages and harmonise across Europe (vitamins, minerals, omega-3s etc) For probiotics it will kill the industry unless consensus is achieved It can be great for brand new products that are well researched (e.g.) Water Soluble Tomato Concentrate

19 Are we Benefitting/Protecting g the Consumer? The Commission think so The member states think so Industry is divided The Parliament are starting to question this fact and will make increasing use of the scrutiny procedure in future The consumer groups are not entirely convinced themselves So the next few months will be just as interesting as the last...

20 Thank You Nigel Baldwin BSc, CSci